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Completed

NCT Number: NCT02360501

Combination of Docetaxel, Cisplatin, and Capecitabine (DCX) in the Treatment of Nasopharyngeal Carcinoma

The standard treatment strategy for locally advanced (stage IVA) and metastatic (stage IVB) nasopharyngeal carcinoma has not been defined yet. Generally induction chemotherapy is given to those patients in order to shrink the tumor volume and facilitate the following radiation therapy. Thus, in this study, the investigators use the combination of Docetaxel+Cisplatin+Xeloda (DCX) to treat locally advanced and metastatic nasopharyngeal carcinoma patients, in order to evaluate the efficacy and safety profiles.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

About this study

The standard treatment strategy for locally advanced (stage IVA) and metastatic (stage IVB) nasopharyngeal carcinoma has not been defined yet. Generally induction chemotherapy is given to those patients in order to shrink the tumor volume and facilitate the following radiation therapy.However, the standard chemotherapy regimen has not been defined yet.Combination of cisplatin and fluracil is the commonly used regimen with tolerable toxicity. Recent studies have found that docetaxel has good efficacy on nasopharyngeal carcinoma patients, and capecitabine can be safely used instead of fluracil. Thus, in this study, we use the combination of Docetaxel+Cisplatin+Xeloda (DCX) to treat locally advanced and metastatic nasopharyngeal carcinoma patients, in order to evaluate the efficacy and safety profiles.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • stage IVA and IVB nasopharyngeal carcinoma
  • at lease one measurable lesion
  • receive no chemotherapy or radiotherapy before
  • Eastern CooperativeOncology Group performance status of 0 to 2.
  • Adequate hematologic function (eg, white blood cell ≥ 3×10e9/l,neutrophils count ≥1.5×10e9/L, and platelet count≥ 100×10e9/L),renal function (eg, serum creatinine≤1.5 mg/dL and creatinine clearance ≥50 mL minute), and hepatic function (e.g, total bilirubin≤ 2 times the upper limit of normal and aspartate and alanine transaminase levels ≤ 3 times the upper limit of normal)

Exclusion criteria

  • mismatch the inclusion criteria
  • previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol.
  • allergy to any of these three drugs

Treatment and study plan

docetaxel

Drug

75mg/㎡,d1

Other names: Taxotere

Cisplatin

Drug

25mg/㎡,d1-3

Capecitabine

Drug

2000mg/㎡,d1-14

Other names: xeloda

Primary outcomes

  1. overall response rate

    Time frame: every 4 weeks,up to completion of treatment(approximately 6 months)

    overall response rate is the sum of complete response rate and partial response rate.

Secondary outcomes

  1. complete response rate

    Time frame: every 4 weeks,up to completion of treatment(approximately 6 months)

  2. 1 year progression free survival rate

    Time frame: date from diagnosis of NPC to disease progression, or death of any cause, whichever comes first (up to 12 months).

  3. 1 year overall survival rate

    Time frame: date from diagnosis of NPC to death of any cause (up to 12 months)

  4. safety profiles (including hematologic toxicities and non-hematologic toxicities.)

    Time frame: date from diagnosis of NPC to completion of study (about 6 months)

    including hematologic toxicities (eg.the incidence rate of neutropenia,thrombocytopenia, and anemia), and non-hematologic toxicities (eg.edema, diarrhea, hand-foot-syndrome).

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Combination of Docetaxel, Cisplatin, and Capecitabine (DCX) in the Treatment of Locally Advanced or Metastatic Nasopharyngeal Carcinoma: a Prospective, Phase 2 Study

Important dates

Study start
2008
Primary completion
2016
Study completion
2016
First posted
Feb 10, 2015
Registry last updated
Apr 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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